Pis (Includes Telzir) ↔ Hemophilia

Severe Potential Hazard, Low plausibility

Applies to: Coagulation Defect

There have been postmarketing reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in types A and B hemophiliac patients treated with protease inhibitors. However, a causal relationship has not been established. In some patients, additional Factor VIII was given. In more than half of the reported cases, protease inhibitor therapy was continued or reintroduced following an interruption. Hemophiliacs and patients with other coagulation defects should be monitored closely for bleeding during protease inhibitor therapy.

Fos-/Amprenavir (Includes Telzir) ↔ Nephrolithiasis

Moderate Potential Hazard, Moderate plausibility

Applies to: Dehydration, Nephrolithiasis, History - Nephrolithiasis

Cases of nephrolithiasis have been reported during postmarketing surveillance in HIV-infected patients receiving amprenavir or fosamprenavir therapy. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. Therapy with amprenavir or fosamprenavir should be administered cautiously in patients with a current or past history of nephrolithiasis. Adequate hydration is recommended. Those who are dehydrated may be at increased risk and should be encouraged to consume additional amounts of liquid or given intravenous fluids if necessary. Patients should be instructed to seek medical attention if they experience potential signs and symptoms of urolithiasis such as flank pain, hematuria, dysuria, and urinary urgency. Temporary interruption or discontinuation of therapy may be required.

Moderate

Pis (Includes Telzir) ↔ Hyperglycemia

Moderate Potential Hazard, Moderate plausibility

Applies to: Abnormal Glucose Tolerance, Diabetes Mellitus

New onset or exacerbation of preexisting diabetes mellitus, glucose intolerance, and hyperglycemia have been reported during postmarketing surveillance in HIV patients treated with protease inhibitors (PIs). Frequently, insulin resistance may accompany fat redistribution and serum lipid elevations in what is collectively termed the HIV-associated lipodystrophy syndrome. Although a causal relationship has not been established, these metabolic disturbances have most often occurred in HIV patients during treatment with potent antiretroviral regimens containing PIs. Patients with or predisposed to glucose disorders should be monitored during PI therapy. Dosage adjustments in insulin or oral hypoglycemic medications may be necessary in patients with diabetes. In some cases, glucose abnormalities persisted despite discontinuation of PI therapy.

Pis (Includes Telzir) ↔ Hyperlipidemia

Hyperlipidemia have been observed in 10% of patients receiving ritonavir during clinical trials. Increases of 30% to 40% from baseline have been reported for total cholesterol and 200% to 300% or more for triglycerides. These effects have also been reported during postmarketing experience with other protease inhibitors (PIs) but may be the most dramatic with ritonavir. The clinical significance of these elevations is unclear. Severe hyperlipidemia is known to sometimes cause pancreatitis. In addition, some patients have reportedly developed symptomatic atherosclerosis and coronary artery disease after initiating PI treatment. Patients with preexisting hyperlipidemia may require closer monitoring during PI therapy, and adjustments made accordingly in their lipid-lowering regimen. PI therapy should be administered cautiously in patients with coronary artery disease or a history of ischemic heart disease.

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